Dental laboratory custom-made devices : legal aspects concerning documentation and import from non-EU/EEA countries
Crowns, bridges, removable dentures and other dental appliances are custom-made medical devices and are subject to specific legislation. The EU directive 93/42 on medical devices constitutes the legislation that regulates dental laboratory custom-made medical devices. This paper investigates how importers of dental laboratory custom-made devices perform quality control and if the legal requirements for information about the medical device are being followed. Questionnaires were sent to eleven dental laboratories and conveyers who advertise import of dental laboratory custom-made devices. Seven replied. Statements that are to accompany dental laboratory custom-made medical devices were collected from Universitetstannklinikken at the University of Tromsø to investigate if they were filled out in accordance with the legal requirements. Although the legislation demands specific labeling of the custom-made devices, this is not adequately performed by the dental technicians. The law is general in its formulations and has its shortcomings in the daily clinical work of dentists and dental technicians. The existing Norwegian guidelines are outdated in some areas. Updated and more specific guidelines can be a helpful tool for dentists and technicians.
PublisherUniversitetet i Tromsø
University of Tromsø
The following license file are associated with this item:
Showing items related by title, author, creator and subject.
Prognostic Impacts of Angiopoietins in NSCLC Tumor Cells and Stroma : VEGF-A Impact Is Strongly Associated with Ang-2 Andersen, Sigve; Dønnem, Tom; Al-Shibli, Khalid Ibrahim; Al-Saad, Samer; Stenvold, Helge; Busund, Lill-Tove; Bremnes, Roy M. (Journal article; Tidsskriftartikkel; Peer reviewed, 2011)Angiopoietins and their receptor Tie-2 are, in concert with VEGF-A, key mediators in angiogenesis. This study evaluates the prognostic impact of all known human angiopoietins (Ang-1, Ang-2 and Ang-4) and their receptor Tie-2, as well as their relation to the prognostic expression of VEGF-A. 335 unselected stage I-IIIA NSCLC-patients were included and tissue samples of respective tumor cells and ...
Cardiovascular adaptation in pregnancy - Effects of angiotensin II, transverse aorta constriction and high-intensity interval training on pregnant rats Songstad, Nils Thomas (Doctoral thesis; Doktorgradsavhandling, 2014-09-18)Objectives: To investigate how cardiac function, remodeling and gene expression are affected in pregnancy in response to cardiovascular stress, to detect possible adverse effects on the fetus, and to evaluate if coronary endothelial function is influenced by pregnancy and increased cardiac afterload. Methods: Pregnant and non-pregnant rats were subjected to chronic AngII-infusion, transverse aortic ...